European Public Assessment Report

A European Public Assessment Report (EPAR) is an assessment produced for all medicines where marketing authorisation is sought through the centralised procedure at the European Medicines Agency (EMA). It is a series of documents, and includes:

• a lay summary,
• details about the marketing authorisation holder,
• product information (such as the package leaflet and summary of product characteristics),
• details about the assessment carried out at EMA.

EPARs are published on the EMA’s website once the European Commission has issued a decision regarding a marketing authorisation.